EXTERNAL FACTORS IMPACTING NEW ONCOLOGY PRODUCTS

PRICING

• When new products are launched, the prices are generally high and keep increasing.
• Prices that increase over 16% in 24 months need to be reported (60 days’ notice).
• Generic brands or copy-cat brands tend to sell products at a lower price which may attract more consumers.
• The U.S. government limits prescription drug prices that are made by manufactures.
• President Donald Trump has made note of the high drug prices and implored Medicare to negotiate lower prices.
• Stakeholders have expressed concerns about the escalating prices with improved innovations as they would rather have a reduction in cost and improved quality.
• To gain more access to drugs, payers are looking for alternative payment options such as the Oncology Care Model (currently restricted to chemotherapy) and the Accountable Care Organizations.
• A company entering the market with new products would likely face challenges because oncology patients get financial assistance for medications. Consequently, a high-priced drug would not be easily sold.

LEGALITIES

• Biosimilars are facing lawsuits over biologic patents, which is affecting its growth rate on the market.
• Companies have to engage in expensive clinical trials before they can enter the market.
• New products also require prior authorizations.
• Legislation is being put in place to control pricing at the state and federal level and California is leading in this area.
• There is legislation, regulations, and advocacy that companies must adhere to in order to market and advertise their products to consumers, strongly supported by the American Medical Association.
• President Donald Trump, in a State of the Union Address, shed light on a policy that allows patients who are terminally ill to access unapproved drugs through the right-to-try legislation. This could pose a challenge for companies that are producing new products in the same area as patients could be less interested in their products if they are offered at high prices.
• It also reduces the number of patients who would once be interested in clinical trials.
•  New products that are supported by the American Society of Clinical Oncology (ASCO) are likely to see an increase in use.

Research Strategy

1. Strategy and Planning for Commercial Launch Success in Pharma

• The key topics presented included; critical success factors of a commercial drug launch, structured road map of the launch process in major therapy areas of oncology immunotherapy, immunology, CNS, CVS and metabolic disorders, market and customer insights, use of the patient journey and leverage points, omnichannel design and launch strategy, and review of best practices.
• The presentations included face-to-face forums with pharma experts, interactive lectures, case studies, group exercises, and discussions with international peers.
• The two-day workshop was delivered by Kurt Arco and Dr. Joeri De Haes.
• The next event is scheduled from 25th to 26th June 2019 in London.
• Past delegates have rated the event 8.7/10 based on recommendations scores.

2. Global Pharmaceutical and Pharma Industry Conference

• This is an international pharmaceutical and pharma industry conference. The key topics presented included; bio-pharmaceutics, pharmaceutical chemistry, drug targeting and design, pharmacokinetics and pharmacodynamics in drugs, pharmaceutical formulation, manufacturing, nanotechnology, drug and vaccine delivery systems, nanomedicine and biomedical applications, bio materials in drug delivery, biosimilars, pharmaceutical analysis, process validation, packaging, clinical trials, pharmacogenetics and genomics, regulatory affairs, pharmacovigilance, and market analysis.
• The presentations were delivered through keynote presentations, oral talks, poster presentations, symposia, workshops, exhibitions, career programs, and B2B meetings.
• The last workshop was held from February 28-March 01, 2019 at Osaka, Japan, and lasted three days.
• The workshop had over 200 participants, 70% of whom were leaders in the pharma industry and 30% academia field.

3. The 3rd Global Pharmaceutical Conference and Expo

• The annual i- Pharma workshop is organized by the ipharma group for pharma and healthcare professionals in the UK and Europe. Key topics presented include; drug design, therapy and discovery, digital pharma and multichannel marketing, innovative drug delivery systems, big data and analytics for pharma, pharmaceutical microbiology, pharmacovigilance, regulatory affairs and clinical trials, cosmeceuticals, orphan drugs, pharmaceutical nanotechnology, pharmaceutical manufacturing operations, pharma packaging, biosimilars, neuropharmacology, biopharmaceuticals, and nutra- pharma integration.
•  Presentations were delivered through workshops, symposiums, plenary sessions, key pharma leaders and company’s insights, interactive panel sessions, and peer discussions.
• The event lasted three days. The next event is scheduled for July 03-05, 2019, London, UK.